A Multicenter, Single-arm, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of HC010 for Injection in the First-line Treatment of Advanced Non-small Cell Lung Cancer Positive for Programmed Death Ligand-1 (PD-L1)
Phase 2 clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity profile of HC010 for injection in patients with positive PD-L1 (TPS ≥1%)
• 1\. Voluntarily participate in the study, communicate well with investigators, understand and voluntarily complete the study process according to this protocol, and sign the informed consent form (ICF).
• 2\. Male or female, aged ≥ 18 years at the time of signing the informed consent form.
• 3\. Histologically or cytologically confirmed locally advanced or metastatic (stage IIIb\
⁃ IV) NSCLC (United States Cancer Confederation \[AJCC\] 8th edition), positive PD-L1 expression confirmed by IHC with central laboratory or local test results.
• 4\. Not previously receiving systemic therapy for locally advanced or metastatic NSCLC; not allowed if the last dose of prior treatment is \<6 months from disease recurrence in subjects who received prior adjuvant or neoadjuvant therapy.
• 5\. No EGFR mutation/ROS1 rearrangement/ALK rearrangement. If other targeted mutations such as BRAF V600E mutation/NTRK1/2/3 gene fusion/MET14 exon skipping mutation/RET rearrangement positive are known, they will not be included in this study if the corresponding targeted therapy drugs have been approved.
• 6\. Expected survival ≥ 3 months.
• 7.There should be at least one measurable lesion according to RECIST v1.1; radiotherapy-experienced lesions may not be selected as target lesions, unless the radiotherapy lesion is the only measurable lesion and clearly progresses based on imaging judgment.
• 8\. Eastern Cooperative Oncology Group (ECOG) performance status scored 0 or 1 in the United States and did not worsen within one week prior to first dose.
• 9\. Subjects (both female and male) agreed to use effective contraception from signing the ICF until 180 days after last dose of investigational product. Female patients of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose; females who are not pregnant or lactating from signing informed consent until 6 months after the last use of investigational drug (including those who agree to stop breastfeeding during this period).